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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035141
Receipt No. R000040037
Official scientific title of the study Investigation for safety of hydrogen rich water administration to systemic inflammatory response
Date of disclosure of the study information 2018/12/05
Last modified on 2018/12/05

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Basic information
Official scientific title of the study Investigation for safety of hydrogen rich water administration to systemic inflammatory response
Title of the study (Brief title) Investigation for safety of hydrogen rich water administration
Region
Japan

Condition
Condition sepsis
after cardiopulmonary resuscitation
Classification by specialty
Emergency medicine Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose is to evaluate the safety of hydrogen rich water administration as a new treatment strategy for systemic inflammatory response.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes To evaluate safety, primary outcome is all adverse event including undesirable or unexpected symptoms and abnormal laboratory test value caused to the patients for one week.
Key secondary outcomes Changes in the intestinal flora over time

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food Device,equipment
Interventions/Control_1 Administration of 150 ml hydrogen rich water (7 ppm) from the nasogastric tube once every 8 hours 3 times a day until the seventh day after admission. Administration of hydrogen rich water start when tube nutrition is started.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) 16 years old and over
2) Severe patient who needs artificial ventilation management at admission
3) Patients with sepsis or after cardiopulmonary arrest resuscitation
Key exclusion criteria 1) Under 16 years old
2) Patients who are possible to die within 48 hours after admission
3) Patients who have gastrointestinal perforation or gastrointestinal bleeding which cannot receive tube nutrition.
4) Heart failure, stroke, respiratory failure due to COPD
Target sample size 10

Research contact person
Name of lead principal investigator Hiroshi Ogura
Organization Osaka University Graduate School of Medicine
Division name Traumatology and Acute Critical Medicine
Address 2-15 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL 06-6879-5707
Email ogura@hp-emerg.med.osaka-u.ac.jp

Public contact
Name of contact person Hiroshi Matsuura
Organization Osaka University Graduate School of Medicine
Division name Traumatology and Acute Critical Medicine
Address 2-15 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL 06-6879-5707
Homepage URL
Email matsuura@hp-emerg.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Graduate School of Medicine Department of Traumatology and Acute Critical Medicine
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 12 Month 05 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 11 Month 15 Day
Anticipated trial start date
2019 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 12 Month 05 Day
Last modified on
2018 Year 12 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040037

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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